Study to Determine the Effect of an Anti-IgE Agent on Inflammatory Cells in the Skin of Atopic Dermatitis Patients

NCT00822783 | Completed Phase 4

• 1 other identifier: CIGE025A2412
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Elevated levels of immunoglobuline E in blood are said to promote the occurence of atopic dermatitis; in fact, many patients with atopic dermatitis have high IgE levels. This study tried to explore whether the depletion of IgE from blood and skin might result in a change of immunological parameters and might alter the clinical course of the disease.

Conditions

Atopic Dermatitis

Keywords

Serum IgE levels; inflammatory cells in the skin; inflammatory cells in the blood; IgE; IgE depletion; atopic dermatitis; atopic eczema; Omalizumab

Study Arms (2)

Omalizumab

ACTIVE COMPARATOR

Drug: Omalizumab

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Omalizumab DRUG

Omalizumab

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• aged between 12 and 60 years
• clinical diagnosis of AD (criteria of Hanifin and Rajka, 1980)
• serum IgE between 30 and 1,300 IU/ml
• at least one significantly positive RAST
• a positive skin prick test of the same specificity as the RAST
• an Investigator's Global Assessment Score of 2 or more at randomization
• stable AD, as defined as active AD (IGA 2 or more) for \> 9 months per year
• signed informed consent.

You may not qualify if:

• pregnant or nursing females or women of childbearing potential who did not use a reliable contraceptive method
• treatment with omalizumab within the last 12 months before study treatment
• known hypersensitivity to any ingredients of omalizumab or omalizumab- related drugs
• elevated serum IgE levels for reasons other than atopy
• ongoing immunotherapy
• use of long-acting antihistamine astemizol within 3 months prior to visit1
• use of medium-acting antihistamines (e.g. loratadine, cetirizine) within 5 days prior to visit 1
• use of short-acting antihistamines (e.g. diphenhydramin, terfenadine) within 3 days prior to visit 1
• use of zafirlukast or other leukotriene receptor inhibitors and zileuton or other 5-lipoxygenase enzyme inhibitors within 3 days prior to visit 1
• use of phototherapy or systemic therapy that is known or suspected to have had an effect on AD within 1 month prior to first application of study medication
• treatment with topical therapy (other than hydrocortisone 1%) that is known or suspected to have had an effect on AD within 14 days prior to first application of study medication
• use of systemic steroids (oral, intravenous, including intraarticular and rectal) within one month prior to first application of study medication. (Patients on a stable maintenance dose of inhaled steroids were allowed to participate)
• use of systemic antibiotics within 2 weeks prior to first application of study medication
• use of tranquilizers, hypnotic agents or tricyclic antidepressants within 2 weeks prior to the start of the study
• immunocompromised patients or patients having a history of malignant disease

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Division of Immunology, Allergy and Infectious Diseases, Department of Dermatology, Medical University of Vienna, Austria.

Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria

Location

Related Publications (4)

• Lane JE, Cheyney JM, Lane TN, Kent DE, Cohen DJ. Treatment of recalcitrant atopic dermatitis with omalizumab. J Am Acad Dermatol. 2006 Jan;54(1):68-72. doi: 10.1016/j.jaad.2005.09.030. Epub 2005 Nov 28.

  PMID: 16384758 BACKGROUND

• Krathen RA, Hsu S. Failure of omalizumab for treatment of severe adult atopic dermatitis. J Am Acad Dermatol. 2005 Aug;53(2):338-40. doi: 10.1016/j.jaad.2005.02.014.

  PMID: 16021135 BACKGROUND

• Maurer D, Ebner C, Reininger B, Fiebiger E, Kraft D, Kinet JP, Stingl G. The high affinity IgE receptor (Fc epsilon RI) mediates IgE-dependent allergen presentation. J Immunol. 1995 Jun 15;154(12):6285-90.

  PMID: 7759866 BACKGROUND

• Maurer D, Fiebiger E, Reininger B, Ebner C, Petzelbauer P, Shi GP, Chapman HA, Stingl G. Fc epsilon receptor I on dendritic cells delivers IgE-bound multivalent antigens into a cathepsin S-dependent pathway of MHC class II presentation. J Immunol. 1998 Sep 15;161(6):2731-9.

  PMID: 9743330 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: October 1, 2001
• Study Completion: April 1, 2003
• Last Updated: January 14, 2009

Record last verified: 2009-01

Locations

AU (1)